Home NDC 62559-890 Bicalutamide
Product NDC 62559-890
11-digit product format 625590890
Labeler code 62559
Product ID 62559-890_cf149c3a-84aa-4ef8-befc-1dbeb7dcc678
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bicalutamide
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA020498
Marketing category NDA
Marketing start 2020-10-26
Substance BICALUTAMIDE
Active strength 50 mg/1
Pharmacologic classes Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020498-001 CASODEX BICALUTAMIDE 50MG TABLET / ORAL AB RLD, RS 1995-10-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020498-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020498-001 CASODEX 50MG TABLET / ORAL AB RLD, RS 1995-10-04 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Bicalutamide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BICALUTAMIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A0Z3NAU9DP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199123 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62559-890-30 Bicalutamide 30 in 1 BOTTLE TABLET 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-890 BICALUTAMIDE TABLET [ANI PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20231220_7a08d88b-051a-4c16-9560-12685c500c58.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62559-890-30 62559089030 30 TABLET in 1 BOTTLE (62559-890-30) 30 tablet 2020-10-26 0000-00-00 No No Current